Suddle Group
Surgical, dental, and ophthalmic instrument OEM/ODM with 45+ years of export history.
Suddle Group is one of Sialkot's largest surgical instrument exporters, producing 20,000+ SKUs including forceps, scissors, retractors, and dental instruments. Their ISO 13485 and FDA-registered facility supplies private-label OEM to medical distributors in over 80 countries.
- Type
- Manufacturer
- Location
- Sialkot, Pakistan
- Founded
- 1976
- Website
- suddlegroup.com
- Categories
- Medical & Healthcare Supplies, Dental Supplies & Equipment
- Markets
- United States, Germany, United Kingdom, Australia
Verified facts
- corporate-mail-on-domain (green), checked 2026-08-09 Mail server of the company domain
- domain-registered (green), checked 2026-08-09 Domain registry record
- web-presence-since (green), checked 2026-08-09 Internet Archive (Wayback)
- debarment-clear (green), checked 2026-08-09 OpenSanctions
- sanctions-clear (green), checked 2026-08-09 OpenSanctions
Claimed certifications
- ISO 9001, Quality Management IAF CertSearch
- ISO 13485, Medical Devices Quality IAF CertSearch
- CE Marking EU NANDO (notified bodies)
- FDA Registered FDA Establishment Registration
Import rules for these goods
- Medical devices sold in the EU must carry CE marking under the Medical Device Regulation (EU) 2017/745, with a conformity assessment matched to the device risk class. European Commission (MDR)
- For the US market, the maker must have an FDA device establishment registration and product listing; most instruments also need 510(k) premarket clearance. US FDA (devices)